Head of Regulatory Affairs Labelling and Clinical Support - Zurich

Location
Glattbrugg, Switzerland
Salary
Competitive
Posted
09 Feb 2021
Closes
26 Feb 2021
Ref
2691
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
About You

At Vifor pharma, we are recruiting for a Head of Regulatory Affairs Labelling and Clinical Support to join our global regulatory affairs department based at our offices in Glattbrugg, Zurich.

This position would suit an experienced regulatory professional with a strong track record of managing large teams and

Key responsibilities:

  • Effective management and leadership of the Regulatory Affairs Labelling & Clinical Support Group


  • Establishment of processes to ensure that strategic& operational support is provided in transparent manner with optimal prioritization and efficiency


  • Accurate and cost-effective resource budget


  • Coordinated scientific approach across Vifor products as evidenced by clinical planning approach in GRA Strategy documents.


  • Lead Regulatory Affairs Labelling & Clinical Support Group: Management of RA Labelling staff, RA Clinical Support group and RA Scientific Writing function


  • Consultation with department product leads to understand support requirements from the Labelling & Clinical Support group


  • Coordination with Head of LCM group (in CoE) to ensure effective dossier support and planning and execution of CCDS rollouts and related submissions


  • Establishment of procedures to manage the group activities in clear and transparent manner including contribution to CSTs, coordination of external scientific writing vendors, provision of regulatory intelligence related to clinical and labelling requirements, etc.


  • Review of tools and staff to ensure optimal support of group activities


  • Representation of GRA on designated governance committees as assigned (e.g. PRC, DRRB, DSB, xCMRST)


  • Delineation of cost-effective solutions and resource, and budgetiong and management of costs accordingly


  • Take on special strategic and organizational responsibilities in consultation with Head Global Regulatory Affairs


Requirements:

  • Degree in life sciences. Masters or PhD in life sciences, or PharmD preferred


  • Significant regulatory experience gained in an international pharmaceutical company with multiple products registered globally


  • Extensive knowledge and experience with pharmaceutical product information and labelling


  • Fundamental understanding of the contents of product dossiers and critical attributes of medicinal products for registration


  • Excellent verbal and written communication skills in English


Required skills:

  • Strong team leadership skills with the ability to build and foster high-performing teams (both functionally and cross-functionally)


  • Demonstrated ability to build effective working relationships and successfully influence at all levels across organizations to achieve business goals


  • Strategic thinker, planner, and implementer with a proven track record practicing sound and timely judgment


  • Self-driven, with high energy and ability to work under stress and set priorities according to needs.


  • Takes a proactive approach in identifying service needs, facilitating flow of information and supporting processes, and maintaining a customer and service oriented approach to all activities.


  • Excellent organizational skills, with an ability to prioritize and to manage complex issues and coordinate multiple projects simultaneously


If this opportunity is of interest to you, please apply by submitting your updated CV via our careers portal.

About Us
At Vifor Pharma, we use our skills, dedication, and entrepreneurial spirit to offer innovative solutions in iron deficiency, nephrology and cardio-renal therapies, so we can help patients around the world live better, healthier lives. This is why we come to work every day.
Are you empowered to create a better world, and be part of life changing work? As a global pharmaceutical company, we offer the chance to be part of a worldwide team, where passion and commitment are met with opportunities for professional and personal development. Learn more at viforpharma.com/career .
What you can expect of us
As we work to support patients, we also take care for our employees' professional and personal growth and well-being. We show appreciation and recognition through attractive benefits that will enhance your life, develop you, empower you to grow, and create your own career journey with us.

Including:
  • Open, safe and inclusive culture that fosters creativity and unleashes individual potential, whether in laboratories, manufacturing sites, in the field, or offices
  • Learning opportunities that enhances your skill set focused on business and personal effectiveness, leadership and management skills, and much more
  • Flexible workplace environment, home office opportunities, competitive vacation entitlement
  • Attractive financial participation schemes, adapted regionally, that provide employees with additional security for every life situation, including: Pension plans, participation schemes, and savings plans
Join Vifor Pharma Talent Community
If you find that the role above is not suitable for your experience or career goals, but you want to keep in touch and learn more about Vifor Pharma and future career opportunities, join our Vifor Pharma Talent Community .